The Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972

Further exemptions from product licences for certain special manufactured products

3.—(1) The restrictions imposed by section 7 of the Act (restriction as to dealings with medicinal products) shall not apply to the sale, supply, or procuring the manufacture or assembly of any medicinal product to which this Article relates if the conditions specified in paragraph (3) of this Article are satisfied.

(2) The medicinal products to which this Article relates are medicinal products which are for use by being administered to one or more human beings and which may be lawfully sold by retail or supplied in circumstances corresponding to retail sale, otherwise than in accordance with a prescription given by a doctor or dentist.

(3) The conditions referred to in paragraph (1) of this Article are—

(i) that the medicinal product is sold or supplied to a person exclusively for use by him in the course of a business carried on by him for the purpose of administering it or causing it to be administered to one or more human beings otherwise than by selling it;

(ii) that, if sold or supplied through a holder of a wholesale dealer's licence or a person entitled to such a licence by virtue of that person's entitlement to a licence of right, the medicinal product is sold or supplied to such person, and for such use by him, as described in sub-paragraph (i) of this paragraph;

(iii) that, where the manufacture or assembly of the medicinal product is procured, it is procured by such person, and for such use by him, as described in sub-paragraph (i) of this paragraph;

(iv) that no advertisement or representation (within the meaning of section 92 of the Act) relating to the medicinal product is issued with a view to it being seen generally by the public in the United Kingdom, that no advertisement relating to that product, by means of any catalogue, price list or circular letter is issued by, at the request or with the consent of, the person selling that product by retail or by way of wholesale or supplying it in circumstances corresponding to retail sale, or the person who manufactures it, and that the sale or supply as aforesaid is in response to a bona fide unsolicited order;

(v) that the medicinal product is prepared by or under the supervision of a pharmacist; and

(vi) that the medicinal product is manufactured by the holder of a manufacturer's licence which relates specifically to the manufacture of medicinal products to which Article 2 of the Special Cases Order and this Article relate, in the latter case by specifying the description of medicinal products in question or by way of an appropriate general classification (including classification by reference to the persons to whom the product is to be sold or supplied).

(4) In respect of medicinal products to which the preceding paragraphs of this Article relate the provisions of subsection (1) of section 23 of the Act (special provisions as to effect of manufacturer's licences) shall have effect as if the holder of the manufacturer's licence in respect of any such products was also the holder of a product licence in respect of such products or as if such products were manufactured or assembled to the order of a person who is the holder of such a product licence.